Director, Manufacturing Engineering
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
- Develops and improves concepts, techniques, and standards.
- Develops new applications based on quality principles and theories.
- Develops solutions to problems of moderate complexity, which require a high degree of ingenuity, creativity and innovativeness.
- Challenges are unique and solutions may serve as precedent for future decisions, which affect the entire organization.
- Interprets, executes, and recommends modifications to company-wide policies to achieve corporate goals and objectives.
- Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums.
- Develops budgets and monitors expenditures.
Specific Education & Experience Requirements:
- 12+ years of relevant experience and a BS or related fields.
- 10+ years of relevant experience and a MA or MBA.
- 8+ years of relevant experience and a PhD.
- Demonstrates deep knowledge and experience in engineering in highly regulated manufacturing environments.
- Has successful experience managing People Managers.
- Has previous experience in biotech or pharmaceuticals industry.
Specific Job Responsibilities:
- Manages personnel, to include organizing and prioritizing group tasks, performing training, and writing performance reviews.
- Performs a wide variety of activities to support operations.
- Develops, implements, and maintains programs and processes to ensure high quality of operations, and compliance with UBC, UFC, NEC codes, current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Works directly with operating entities to ensure that equipment maintenance, safety inspections, analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Reviews and approves training matrix.
- Interfaces with contractor to establish relationships for Manufacturing and property administration oversight and inter-company effective communication to address documentation and compliance issues.
- May interface with regulatory agencies as required.
- May write and/or implement changes to controlled documents as needed.
- Develops budgets and monitors expenditures.
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Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​
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